Akupunktur bei Aromatasehemmer induzierten Gelenkschmerzen

Abstract

Importance. Musculoskeletal symptoms are the most common adverse effects of aromatase inhibitors and often result in therapy discontinuation. Small studies suggest that acupuncture may decrease aromatase inhibitor-related joint symptoms. Objective. To determine the effect of acupuncture in reducing aromatase inhibitor-related joint pain. Design, Setting, and Patients. Randomized clinical trial conducted at 11 academic centers and clinical sites in the United States from March 2012 to February 2017 (final date of followup, September 5, 2017). Eligible patients were postmenopausal women with early-stage breast cancer who were taking an aromatase inhibitor and scored at least 3 on the Brief Pain Inventory Worst Pain (BPI-WP) item (score range, 0–10; higher scores indicate greater pain). Interventions. Patients were randomized 2:1:1 to the true acupuncture (n = 110), sham acupuncture (n = 59), or waitlist control (n = 57) group. True acupuncture and sham acupuncture protocols consisted of 12 acupuncture sessions over 6 weeks (2 sessions per week), followed by 1 session per week for 6 weeks. The waitlist control group did not receive any intervention. All participants were offered 10 acupuncture sessions to be used between weeks 24 and 52. Main Outcomes and Measures. The primary end point was the 6-week BPI-WP score. Mean 6-week BPI-WP scores were compared by study group using linear regression, adjusted for baseline pain and stratification factors (clinically meaningful difference specified as 2 points). Results. Among 226 randomized patients (mean [SD] age, 60.7 [8.6] years; 88% white; mean [SD] baseline BPI-WP score, 6.6 [1.5]), 206 (91.1%) completed the trial. From baseline to 6 weeks, the mean observed BPI-WP score decreased by 2.05 points (reduced pain) in the true acupuncture group, by 1.07 points in the sham acupuncture group, and by 0.99 points in the waitlist control group. The adjusted difference for true acupuncture vs sham acupuncture was 0.92 points (95% CI, 0.20–1.65; P = 0.01) and for true acupuncture vs waitlist control was 0.96 points (95% CI, 0.24–1.67; P = 0.01). Patients in the true acupuncture group experienced more grade 1 bruising compared with patients in the sham acupuncture group (47% vs 25%; P = 0.01). Conclusions and Relevance. Among postmenopausal women with early-stage breast cancer and aromatase inhibitor-related arthralgias, true acupuncture compared with sham acupuncture or with waitlist control resulted in a statistically significant reduction in joint pain at 6 weeks, although the observed improvement was of uncertain clinical importance. Trial Registration. ClinicalTrials.gov Identifier: NCT01535066. Kommentar Aromataseinhibitoren (AIs) haben sich in der Therapie des hormonabhängigen Mammakarzinoms (rund 80 % aller Brustkrebsfälle) als effektiv erwiesen [1, 2]. Nebenwirkungen verhindern aber häufig eine langfristige Anwendung. Der häufigste Grund für einen Therapieabbruch sind Gelenkschmerzen [3]. In der hier vorgestellten randomisiert kontrollierten Studie (Randomized Controlled Trial, RCT) untersuchten Hershman und Kollegen die Wirksamkeit der Akupunktur bei AI-induzierten Gelenkschmerzen gegenüber einer Scheinakupunktur und keiner Behandlung (Warteliste; [4]). Die Patientenrekrutierung erfolgte an 11 Studienzentren (universitäre und kommunale Versorgungseinrichtungen). Die eingeschlossenen Patientinnen litten an einem invasiven, östrogenoder progesteronabhängigen, nichtmetastasierten Mammakarzinom (Stage I–IIII). Sie waren postmenopausal oder nahmen GNRH(Gonadotropin-Releasing-Hormone)-Antagonisten ein. Operationen oder Chemotherapie mussten abgeschlossen und der Allgemeinzustand gut sein (Zubrod Performance Status 0–1). Die Gelenkschmerzen sollten nach einer mindestens 30-tägigen AI-Einnahme (3. Generation) aufgetreten sein. Die maximale Schmerzintensität musste mindestens 3 auf der entsprechenden Subskala des Brief Pain Inventory-Short Form (BPI-SF, Journal Club Deutsche Zeitschrift für Akupunktur 2019 • 62 (3): 176–178 https:// doi.org/ 10.1007/ s422120190196-2 Online publiziert: 17. Juli 2019 © Springer Medizin Verlag GmbH, ein Teil von Springer Nature 2019